Description

Pregabalin Impurity 28 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) pregabalin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in pregabalin API and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance: Employed in routine QC testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Used to track the formation of degradation products in pregabalin formulations under various stress conditions.
• Research & Development: Facilitates synthetic route optimization and process chemistry research by identifying and characterizing process-related impurities.

Basic Information

Product Name	Pregabalin Impurity 28
CAS No.	1026009-73-3
Molecular Formula	C8H17NO2
Molecular Weight	159.23 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-3-Isobutyl GABA; Pregabalin Related Compound 28; Pregabalin EP Impurity G; Pregabalin USP Impurity; Lyrica Impurity 28
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 28 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, NMR), assay (by HPLC), and related substance analysis. We adhere to relevant pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.